Decision in Lawsuit Allowing Medical Device DMCA Exemption Reversed in Appeals Court

On June 7, 2024, the U.S. Court of Appeals issued a decision reversing the U.S. District Court dismissal of the challenge by MITA and AdvaMed to the Librarian of Congress’ granting of an exemption from the Digital Millenium Copyright Act’s (“DMCA”) anti-circumvention provision pertaining to medical device manuals. Two independent medical device servicers had sought [...]

Inaugural Healthcare ‘Chief Competition Officer’ Appointed by HHS

January 10, 2024 By Robert J. Kerwin On Monday the U.S. Department of Health and Human Services announced the creation of a new HHS officer position entitled ‘chief competition officer’ to promote competition and lower health care costs. Stacy Sanders, most recently counselor to HHS secretary Xavier Becerra, will assume the role. While some industry [...]

By |2024-01-11T17:02:43+00:00January 11th, 2024|Government, Healthcare|Comments Off on Inaugural Healthcare ‘Chief Competition Officer’ Appointed by HHS

FDA to Amend Quality System Regulation

In its continued efforts to harmonize with international regulatory authorities, the  U.S. Food & Drug Administration has an nounced its intention to amend the current  good manufacturing practice requirements  of the FDA quality system regulation, 21  C.F.R 820 et seq. to align more closely with  the international consensus standard for  devices, ISO 13485. This is [...]

By |2022-06-08T16:47:58+00:00June 8th, 2022|Government, Healthcare|Comments Off on FDA to Amend Quality System Regulation

OEM trade groups may be seeking to expand definition of ‘remanufacturing’ quickly and quietly

An op-ed by Robert J. Kerwin As the 2021 Federal Trade Commission (FTC) report to Congress on repair restrictions acknowledged, some medical equipment manufacturers are limiting the availability of diagnostic software and firmware necessary to make repairs. That situation may soon worsen, if legislation proposed by a manufacturer trade association is filed and approved. This [...]

By |2022-03-24T14:08:38+00:00March 24th, 2022|Business, Government, Healthcare|Comments Off on OEM trade groups may be seeking to expand definition of ‘remanufacturing’ quickly and quietly

Copyright Ruling May Pave Way for Greater Access to Medical Device Service Manuals

Two months ago, a little-known rulemaking proceeding was underway at the U.S. Copyright Office which, depending upon the outcome, was poised to have favorable implications for the use of electronic medical device equipment manuals by servicers. Today, the Librarian of Congress issued a ruling to accept for the next three years the recommendation of the [...]

By |2021-11-02T12:15:49+00:00November 2nd, 2021|Government, Governments, Healthcare, Legal Advice, Reform, Regulatory|Comments Off on Copyright Ruling May Pave Way for Greater Access to Medical Device Service Manuals

FDA Says Sharing Device Manuals With ISOs Does Not Create Cybersecurity Concerns

A little-known rulemaking proceeding is underway at the U.S. Copyright Office which, depending upon the outcome, may have profoundly favorable implications for the use by servicers of electronic medical device equipment manuals. Every three years under the Digital Millennium Copyright Act (“DMCA”), the Librarian of Congress, upon receipt of the recommendation of the Register of [...]

By |2021-09-07T17:35:30+00:00September 7th, 2021|Business, Government, Governments, Healthcare, Imaging, Legal Advice, Reform, Regulatory, Used Medical Equipment|Comments Off on FDA Says Sharing Device Manuals With ISOs Does Not Create Cybersecurity Concerns

FDA Remanufacturing Guidance Comment Period Extended

On June 24, 2021, the FDA released a draft version of the FDA Remanufacturing Guidance. At the request of industry, the time frame for providing written comments to the guidance has been extended to September 22, 2021. In 2018, the agency disseminated a remanufacturing white paper, and now the circulation of a draft guidance indicates [...]

By |2021-08-05T21:07:51+00:00August 5th, 2021|Business, Government, Healthcare|Comments Off on FDA Remanufacturing Guidance Comment Period Extended

Brexit agreement begins now: Are you ready?

By Robert J. Kerwin It was four years ago that Britain’s then-prime minister, David Cameron, set a referendum on  the U.K.’s continued membership in the European Union. In June 2016, the citizens of the U.K.  voted to leave the EU.  In January 2020, the U.K. officially withdrew, and since that time the EU and the [...]

By |2021-01-06T03:54:31+00:00January 6th, 2021|Business, Government, Healthcare|Comments Off on Brexit agreement begins now: Are you ready?

FDA adverse event reporting form to include question as to third-party service

By Robert J. Kerwin Medical device manufacturers, importers, distributors and user facilities have long been required to report deaths, serious injuries and malfunctions that have, may have or would be likely to cause or contribute to a death or serious injury. The FDA regulation pertaining to "user facilities" provides that reports should be filed on [...]

By |2020-10-02T12:49:18+00:00October 2nd, 2020|Government, Healthcare|Comments Off on FDA adverse event reporting form to include question as to third-party service

First federal ‘right to repair’ legislation filed in US to help hospitals through pandemic

An opinion piece by Robert J. Kerwin Senator Ron Wyden (D-Ore) and Rep. Yvette Clark (D-NY) filed today in the U.S. Senate and the U.S. House of Representatives the first federal right to repair legislation. “There is no excuse for leaving hospitals and patients stranded without necessary equipment during the most widespread pandemic to hit [...]

By |2020-08-10T16:14:06+00:00August 10th, 2020|Government, Healthcare|1 Comment
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